Modi 2013.
Methods |
Study design: RCT Method of randomisation: via a permuted block randomisation method with block size of 2. Setting: a new‐onset seizure clinic at a pediatric children’s hospital in the USA. Date it was conducted: not reported. Follow up: 4 months. Source of funding: National Institute of Health Conflict of interest: the authors declare no conflict of interest. |
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Participants |
inclusion/exclusion criteria: diagnosis of a non epilepsy medical disorder requiring daily medication, a significant developmental disorder (e.g. autism), or the family living >90 miles away from the hospital. Families had to read/speak English. Sample size: 40 families were approached for study participation; 30 agreed to participate and 3 withdrew before randomisation or did not return. After a 1‐month run‐in period, participants with near perfect adherence (> 90%) were monitored (n = 19). Participants with adherence < 90% (n = 8) were randomly assigned to IG or to the CG group. Age: mean age was 8.0 years (SD 5.6) in the IG and 7.1 years (SD 2.3) in the CG. Gender: 50% male Other characteristics: mean duration since diagnosis was 3.2 months (SD 1.2) in the IG group and 1.5 months (SD 0.88) in the CG |
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Interventions |
Type of intervention: educational The IG received 4 sessions over > 2 months. The first component of the intervention (session 1) provided education on epilepsy treatment, AED adherence and the family’s specific epilepsy treatment regimen (i.e. dosing schedule). Sessions 2 through 4 aimed to teach families a problem‐solving approach for their identified AED‐adherence barriers. |
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Outcomes |
Primary outcome(s) measured: adherence It was measured by an electronic monitoring system that measures the time and date a pill bottle and cap were opened. Secondary outcome(s) measured: assessment of feasibility and acceptability of the adherence Intervention. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Permuted block randomisation with block size of 2 was described |
Allocation concealment (selection bias) | Unclear risk | No information on concealment was reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding was reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding was reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across groups with similar reasons for missing data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | Insufficient rationale or evidence that an identified problem will introduce bias |